India – A Critical Player in Global Clinical Research

Dr. Anoop K. Agarwal

What is Outsourcing?

• Transfer in full or part of the business activities to an outside entity.

• This may include transfer of – Business Processes – Procedures– Responsibilities

WATERSHED YEAR 2005

Several major events occurred in 2005 making it watershed year.

Amendment to Schedule Y Passage of IPR bill Launch of CDSCO/ WHO- GCP training programmes. First USFDA inspection of a global trial Launch of Pharmacovigilance programme Ministry of

Health & World Bank (6 centres)

SponsorInvestigator

/ SitePatient

CRO

SMO

IRB/IEC

The Players in Clinical Research

Regulators

India - Natural choice for CR services

Easy Access of patient recruitment

Well-trained medical community to global

standards

Rapidly increasing awareness of GCP

English as a primary language of education and

communication

100 million English speaking people (Largest outside US)

India - Natural choice for CR services

“Right” patient pool Genetically & culturally diverse population

Treatment- naïve patients from multiethnic and multiracial

backgrounds

Wide spectrum of diseases

Speed of patient recruitment

IPR / WTO, GATT on board

Cost effective operations

Presence of all Pharma majors

Facts & Figures

40 million patients with cardiovascular diseases

35 million with Type 2 diabetes

10 million with psychiatric disorders

2 million cases of cancer with 5,00,000 cases

detected every year

Recruits for genetic studies

Facts & Figures

600,000 practicing physicians

14,000 hospitals

7,00,000 beds

17,000 medical graduates per year

Estimated no. of GCP trials conducted in 2010: 300 – 350

Estimated no. of GCP trained PIs in 2010: 3000 - 3500

India – Favorable destination for Clinical Trials

• CR industry will witness a business of Rs 10,000 crore creating a demand of 50,000 professionals in the next 5 yrs (McKinsey Report)

• By 2012 up to 5% of global trials will take place outside USA & Western Europe

• 2003-04, not > 20,000 patients participated in global trials, estimated that 20% of all patients in global trials could be from India

Projected Growth of Indian CR Industry

Resources 2012

CR market $1.5 Billion

GCP Studies 1500-2000

GCP Trained Drs. 10000-15000

Subjects reqd. 200000-300000

CR Professionals 50000

In preparation for this role…

• ICMR improving facilities for CT & drug development research -10 yrs– Advanced centers in toxicology, clinical pharmacology,

reproductive toxicology, CTs of medicinal plants & herbs .

• No trial can be conducted in India without the approval of the DCGI

• Ministry of Environment & Forests to approve genetically modified drugs, before DCGI

Widening Operations of CROs

• No. of companies participating in CR is increasing

• Large Indian pharma companies (Wockhardt, Sun

Pharma, Lupin) working on NCEs. They have established their own CR units to conduct trials for their new molecules.

Widening Operations of CROs

• Central / Referral Labs (Dr. Lal’s Lab, Metropolis Health

Services, SRL Ranbaxy) are offering CT services• IT Companies (Cognizant, Eassar, HCL, IBM, Infosys & TCS),

making investments in Data Management

CROs in India

• > 250 CROs in India• Many pharma Cos. have their own CR Units

conducting trials in 250-300 government & private hospitals.

• E.g. Eli Lilly is conducting 17 global & local CTs in 65 locations

Clinical Research Market

est McKinsey 2003 Assumption USD = Rs. 45

Year Indian market

(Rs. in cr.)

Indian Market (million $)

[% of global]

Global Market

(million $)

2003 315 70 [1.16 %] 5000 - 6000

2004 450 100 [1.11 %] 9,000

2005 810 180 [1.80 %] 10,000

2007 2700 600 [2.26% of US] 26,500 US + Rest

2010 3000 700 [2 %] 50,000

3-Year Employment GrowthGlobal Pharmaceutical Industries

6.0%

4.2%

2.0%1.7% 1.5%

0%

2%

4%

6%

8%

Asia LatinAmerica

US Canada W.Europe

Source: PhRMA, CenterWatch Aanalysis

Growth rate

Staff Distribution in Indian CROs

18.9

46.39

4.06

22.68

14.83

7.9

0 10 20 30 40 50

Corporate

Clin Ops

Bus.Dev

Lab. Serv

Data Mgmt

IT

Source: Data on File

Key Qualifications Sought

Experience59%

Flexibility4%Attitude

11%

Degree16%

Communication Skills4% Work Ethic

2%

Computer Skills2%

Organizational Skills

2%

Source: CenterWatch Survey

Changes in Roles & Responsibilities During Past 3 Years

66.7%

48.6%

46.6%

14.4%

0% 20% 40% 60% 80% 100%

Significantly changedroles & responsibilities

Changed employer

Received a promotion

Relocation

N = 1771

Source: ACRP Outlook

Technologies & Clinical Trials

14% 16%

5%

17%

45%

58%60%

52%

0%

20%

40%

60%

80%

100%

Electronic CRF RDE Internet-based ClinicalData Management

Electronic MedicalRecords

Currently Use Often Will Use Often in 2 yearsPercent of Total

Source: ACRP Outlook

Clinical Research-A Regulated Approach

• ICH-GCP guidelines• Indian GCP• Schedule Y• Biomedical Ethics

New “Drug” - Indian Regulations

• New device, Any intervention, Vaccine• A drug discovered abroad must be evaluated

in India• Mandatory clinical trials

e.g: HIV vaccine trials

Patent Act opens up vast business opportunities for Indian Companies

• Positive transformation, will improve nation’s image in the world

• Product patents • Boost R&D & will help to bring in foreign direct

investment in the industry & contribute to healthcare• Major opportunity for MNC pharma by launching

patented new products• “India will get an estimated revenue of US $10 billion

thru’ the new patent regime”. » Dr. William Haseltine

Head - MSAB

There is no second chance !

• Clinical research is not a BPO• Whether done in Delhi or Dallas, needs the

same scientific scrutiny & ethics• No short cuts & half measures • Because…

Have you seen geese heading south for winter

flying along in V formation? As each bird flaps its wings, it

createsan uplift for the bird immediately

following.By flying in V formation the whole

flock addsat least 77% greater flying range, than if each bird flew on its own.

People who share a common direction

and sense of community can get

where they are going more quickly

and easily because they are travelling

on the thrust of one another.

THANK YOU FOR YOUR THANK YOU FOR YOUR KIND ATTENTION !KIND ATTENTION !